Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use.

Why Should You Attend

This webinar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use.

This webinar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audit and how to become part 11 compliant.

Areas Covered in this Webinar

Requirements and approaches for Analytical Instrument QualificationGoing through the qualification phasesTesting and deviation handlingRetrospective qualification and RequalificationEquipment Maintenance and Change controlType and extend of qualification for USP Instrument CategoriesRequirements and approaches for Laboratory Computer SystemsValidation of Laboratory Computer systemsValidation and Use of Excel in the QC LaboratoryPeriodic review and revalidation of chromatographic data systemHandling raw data and other laboratory recordsEnsuring Integrity and Security of Laboratory (Raw) data for FDA validation trainingAuditing Laboratory Computer Systems and records for FDA compliance training

Learning Objectives

Learn about the regulatory background and requirements for laboratory instrument qualification and system validationUnderstand the logic and principles of instrument qualification and system validation from validation planning reportingUnderstand and be able to explain your company’s qualification and validation strategiesBe able to independently prepare execute test protocols, this includes setting specifications and acceptance criteriaUnderstand how to review and approve qualification and validation protocolsBe able to develop inspection ready qualification and validation deliverablesLearn how to avoid and/or respond to FDA inspectional observations and warning letters

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab.

In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

Seminar Summary:

FDA compliance training on instrument qualification and validation to prepare for FDA audit and to be part 11 compliant (see
full course description)